EP1501487A1 - Kapselzusammensetzung - Google Patents

Kapselzusammensetzung

Info

Publication number
EP1501487A1
EP1501487A1 EP03715199A EP03715199A EP1501487A1 EP 1501487 A1 EP1501487 A1 EP 1501487A1 EP 03715199 A EP03715199 A EP 03715199A EP 03715199 A EP03715199 A EP 03715199A EP 1501487 A1 EP1501487 A1 EP 1501487A1
Authority
EP
European Patent Office
Prior art keywords
capsule
aldehyde group
capsule preparation
composition
vitamin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03715199A
Other languages
English (en)
French (fr)
Inventor
Hiroshi Capsugel Japan Inc. OHNUKI
Eisaku Capsugel Japan Inc. SAI
Kenji Capsugel Japan Inc. MIYATA
Takahisa Capsugel Japan Inc. TAKUBO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warner Lambert Co LLC
Original Assignee
Warner Lambert Co LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Warner Lambert Co LLC filed Critical Warner Lambert Co LLC
Publication of EP1501487A1 publication Critical patent/EP1501487A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals

Definitions

  • the present invention relates to a novel capsule preparation and, specifically, to a capsule preparation with stable appearance quality into which vitamin C or the like is filled.
  • Capsule preparations prepared by filling a drug into a gelatin capsule are known.
  • capsule preparations prepared by filling vitamin C or the like into a gelatin capsule have a problem that the capsule turns brown with the passage of time, exerting a fatal influence upon the appearance quality.
  • the inventors of the present invention have conducted intensive studies to solve the above problem and have accomplished the present invention.
  • the present invention relates to a capsule preparation prepared by filling a medical formulation, food or food additive which has an aldehyde group in the molecule, or readily forms an aldehyde group, into a capsule made of pullulan as a base.
  • Pullulan is a linear ⁇ -glucan wherein -1,4 bonded maltotrioses are repeatedly polymerized at both terminals through -l,6-bond and it is a water-soluble polysaccharide produced outside the body by Aureobasidium pullulans.
  • the capsule made of pullulan as a base can be produced by a known method.
  • WO/01/07507 PTC/EP00/06843
  • it can be preferably produced by an immersion molding method in which a capsule is formed from a film forming composition containing pullulan and a cured system using a capsule production machine which is commonly used for the production of a hard gelatin capsule.
  • Fig. 1 The photos show the inspection result of the capsule made of gelatin as a base (left photo) of the capsule preparation and the capsule made of pullulan as a base (right photo) of the capsule preparation, after six weeks of preservation.
  • a large number of medical formulations, foods or food additives which have an aldehyde group in the molecule, or readily form an aldehyde group, are present and all of them can be used in the present invention.
  • monosaccharides and derivatives thereof such as erythrose, threose, ribose, arabinose, xylose, lyxose, allose, glucose, mannose, gulose, idose, galactose and talose
  • food additives such as anisaldehyde, L-perillaldehyde, ⁇ -amylcinnamaldehyde, cinnamaldehyde, benzaldehyde, decanal, octanal, vanillin, ethyl vanillin, citral, citronellal, hydroxycitronellal, dibenzoylthiamin, dibenzoylthiamin hydrochloride, bisbent
  • vitamin Bl fursultiamine hydrochloride
  • the capsule preparation of the present invention contains a medical formulation, food or food additive which has an aldehyde group in the molecule, or readily forms an aldehyde group, such as vitamin C, the discoloration of the capsule with the passage of time is prevented or suppressed and its good appearance quality is retained.
  • the mechanism that the discoloration is prevented or suppressed by the present invention is unknown but it is considered that the Maillard reaction between the capsule base material and a formulation, food or food additive such as vitamin C is suppressed.
  • a capsule which was made of pullulan as a base and colored white with titanium oxide was produced in the same manner as in Example of WO/01/07507. That is, 20 g of hydrolyzed, deoiled lecithin, 363 g of ⁇ -carrageenan and 40 kg of pullulan were dispersed into 142 liters of deionized water by heating at 70°C with agitation. An aqueous solution containing 455 g of potassium acetate was added to this mixture. 3 liters of the thus prepared pullulan solution, 3 liters of hot water and 800 g of titanium dioxide were mixed together and defoamed to prepare a slurry solution at 60°C. A white, opaque hard pullulan capsule was produced from this slurry in the same manner as a hard pullulan capsule was.
  • the pullulan capsule preparation obtained in Example 1 and the gelatin capsule preparation for comparison were placed in a high-density polyethylene container with a cover and preserved under an environment of 40°C and a humidity of 75% for 6 weeks. After preservation, the appearance quality of the capsules in the capsule preparations was inspected with the naked eye.
  • the capsule preparation of the present invention can retain its good appearance quality because the discoloration of the capsule with the passage of time is prevented or suppressed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Jellies, Jams, And Syrups (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
EP03715199A 2002-04-24 2003-04-14 Kapselzusammensetzung Withdrawn EP1501487A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2002121941 2002-04-24
JP2002121941A JP2003313125A (ja) 2002-04-24 2002-04-24 カプセル剤
PCT/IB2003/001507 WO2003090725A1 (en) 2002-04-24 2003-04-14 Capsule preparation

Publications (1)

Publication Number Publication Date
EP1501487A1 true EP1501487A1 (de) 2005-02-02

Family

ID=29267425

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03715199A Withdrawn EP1501487A1 (de) 2002-04-24 2003-04-14 Kapselzusammensetzung

Country Status (12)

Country Link
US (1) US20030219478A1 (de)
EP (1) EP1501487A1 (de)
JP (1) JP2003313125A (de)
KR (1) KR100625386B1 (de)
CN (1) CN1306931C (de)
AU (1) AU2003219388B2 (de)
BR (1) BR0309324A (de)
CA (1) CA2482936A1 (de)
EA (1) EA006999B1 (de)
MX (1) MXPA04009921A (de)
NZ (1) NZ535841A (de)
WO (1) WO2003090725A1 (de)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4031232B2 (ja) * 2001-11-09 2008-01-09 カプスゲル・ジャパン株式会社 新規カプセル
EP1721604A4 (de) * 2004-03-04 2008-04-30 Takeda Pharmaceutical Stabiles kapselpräparat
CN112294837A (zh) * 2020-11-17 2021-02-02 广州三三医药生物科技有限公司 一种精氨酸牛磺酸谷氨酰胺胶囊及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3784390A (en) * 1971-07-23 1974-01-08 Hayashibara Biochem Lab Shaped bodies of pullulan and their use
US3871892A (en) * 1972-12-18 1975-03-18 Hayashibara Biochem Lab Shaped bodies of pullulan esters and their use
JPH0565222A (ja) * 1991-09-09 1993-03-19 Fuji Capsule Kk カプセル剤用プルラン配合皮膜及びカプセル剤
US5935584A (en) * 1994-01-13 1999-08-10 Elizabeth Arden Company Vitamin C delivery system
US6030641A (en) * 1997-06-03 2000-02-29 Uni Colloid Kabushiki Kaisha Sustained release capsule and method for preparing the same
AUPP022297A0 (en) * 1997-11-06 1997-11-27 R.P. Scherer Holdings Pty Ltd Vitamin coating
US5955102A (en) * 1998-09-04 1999-09-21 Amway Corporation Softgel capsule containing DHA and antioxidants
DE60020716T2 (de) * 1999-07-22 2005-12-15 Warner-Lambert Co. Llc Filmbildende zusammensetzungen aus pullulan
US6916796B2 (en) * 2002-06-12 2005-07-12 Abbott Laboratories Use of pullulan as a slowly digested carbohydrate
JP2005187376A (ja) * 2003-12-25 2005-07-14 Shin Etsu Chem Co Ltd 低置換度セルロースエーテル含有カプセル及びその製造方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
None *
See also references of WO03090725A1 *

Also Published As

Publication number Publication date
AU2003219388B2 (en) 2007-10-18
EA006999B1 (ru) 2006-06-30
WO2003090725A1 (en) 2003-11-06
US20030219478A1 (en) 2003-11-27
KR100625386B1 (ko) 2006-09-20
CA2482936A1 (en) 2003-11-06
JP2003313125A (ja) 2003-11-06
CN1646106A (zh) 2005-07-27
EA200401119A1 (ru) 2005-06-30
AU2003219388A1 (en) 2003-11-10
NZ535841A (en) 2006-08-31
KR20040111544A (ko) 2004-12-31
MXPA04009921A (es) 2005-06-17
BR0309324A (pt) 2005-04-12
CN1306931C (zh) 2007-03-28
HK1075003A1 (en) 2005-12-02

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